Personalized Robotic Telerehabilitation for Upper Limb Functional Recovery After Stroke in a Home-Based Setting (ROBOHOME)

Stroke is a leading cause of long-term disability worldwide, with upper-limb impairment representing a major determinant of functional limitation and reduced independence. Conventional rehabilitation approaches are often limited by accessibility, intensity, and long-term adherence, highlighting the need for innovative, home-based solutions.

This study aims to evaluate the effectiveness of a personalized robotic telerehabilitation program for upper-limb recovery in individuals with post-stroke motor impairment. The intervention combines a wearable robotic device with a virtual reality-based platform, enabling patients to perform structured, task-oriented exercises in a home environment under remote supervision.

Participants will be allocated to either a robotic-assisted telerehabilitation program or a control condition based on virtual reality-based rehabilitation alone. Motor recovery will be assessed using standardized clinical scales, including the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), along with measures of functional performance, patient-reported outcomes, and treatment adherence.

By integrating robotic assistance with telemedicine, this study seeks to enhance rehabilitation intensity, improve patient engagement, and facilitate continuity of care beyond traditional clinical settings. The results are expected to support the development of accessible, personalized rehabilitation pathways for individuals with stroke-related upper-limb disability.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Rehabilitation; Hemiparesis; Upper Extremity Paresis; Motor Impairment
• Intervention / Treatment: Device: Robotic-Assisted Telerehabilitation Virtual Reality-Based Telerehabilitation; Other: Virtual reality-based rehabilitation platform without robotic assistance

Detailed Description

This multicenter, prospective, randomized controlled trial aims to evaluate the effectiveness of a personalized telerehabilitation protocol integrating a wearable robotic device with a virtual reality (VR)-based platform in individuals with post-stroke upper-limb impairment.

Stroke-related upper-limb dysfunction significantly affects daily activities, social participation, and quality of life. According to the International Classification of Functioning, Disability and Health (ICF), participation is a key outcome; however, upper-limb disability represents a major barrier to inclusion.

Robotic rehabilitation and advanced technologies have demonstrated clinical effectiveness in improving motor function. However, their use is mainly limited to specialized centers. Home-based telerehabilitation enables continuity of care, enhances treatment intensity, and supports long-term recovery, while reducing the need for in-person sessions.

The intervention combines:

a wearable robotic device (EMOVO), a virtual reality telerehabilitation platform (VRRS Home Kit).

Participants will undergo a structured 4-week rehabilitation program consisting of daily 60-minute sessions administered at home and remotely supervised by rehabilitation professionals.

Participants will be randomized into:

an experimental group receiving robotic-assisted telerehabilitation, a control group receiving VR-based telerehabilitation alone.

The study will evaluate motor recovery, functional performance, patient-reported outcomes, treatment adherence, user satisfaction, and safety.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MARCO PAOLETTA, Researcher; Phone Number: +393922123028; Email: marco.paoletta@unicampania.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 years or older
• Diagnosis of stroke with residual upper-limb motor impairment
• Upper-limb functional impairment defined by a Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 20 and 50
• Ability to understand study procedures and provide written informed consent
• Availability of a home environment suitable for telerehabilitation

Exclusion Criteria:

• Presence of severe neurological or musculoskeletal disorders affecting the upper limb
• Severe spasticity (Modified Ashworth Scale ≥3)
• Severe upper-limb pain (Numerical Rating Scale >4)
• Skin lesions, infections, or conditions preventing safe use of wearable devices
• Participation in another interventional clinical trial
• Any medical or cognitive condition that may interfere with compliance or safe participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic-Assisted Telerehabilitation for Upper Limb Recovery; Participants assigned to this arm will receive a home-based telerehabilitation program supported by a wearable robotic device integrated with a virtual reality-based rehabilitation platform. The intervention consists of daily 60-minute sessions over a 4-week period and includes passive and active-assisted upper-limb mobilization, grasping and releasing exercises, task-oriented activities, and interactive exergaming exercises. All sessions will be remotely supervised by a physiotherapist, with individualized adjustments based on participant performance and progression.	Device: Robotic-Assisted Telerehabilitation Virtual Reality-Based Telerehabilitation; Experimental: Robotic-Assisted Telerehabilitation for Upper Limb Recovery Arm Description: Participants assigned to the experimental group will receive a home-based telerehabilitation program supported by a wearable robotic device integrated with a virtual reality-based rehabilitation platform. The intervention consists of daily 60-minute sessions over a 4-week period, including passive and active-assisted upper-limb mobilization, task-oriented exercises, and exergaming activities, with remote supervision by a physiotherapist.
Active Comparator: Virtual Reality Telerehabilitation Without Robotic Support; Participants assigned to this arm will receive a home-based telerehabilitation program delivered through a virtual reality-based rehabilitation platform. The intervention consists of daily 60-minute sessions over a 4-week period and includes upper-limb mobilization exercises, task-oriented training, and interactive exergaming activities. All sessions will be remotely supervised by a physiotherapist to ensure correct execution and adherence to the rehabilitation protocol.	Other: Virtual reality-based rehabilitation platform without robotic assistance; Active Comparator: Virtual Reality Telerehabilitation Without Robotic Support Arm Description: Participants assigned to the control group will receive a home-based telerehabilitation program delivered through a virtual reality-based rehabilitation platform. The intervention consists of daily 60-minute sessions over a 4-week period, including upper-limb mobilization exercises, task-oriented training, and interactive exergaming activities. All sessions will be remotely supervised by a physiotherapist to ensure correct execution and adherence to the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in upper-limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE)	The primary outcome is the change in upper-limb motor function measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), comparing baseline (pre-intervention) and post-treatment values. The FMA-UE is a validated, stroke-specific scale that evaluates motor recovery and functional impairment of the upper limb.	Baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Box and Block Test (BBT)	Assessment of manual dexterity and upper-limb functional performance using the Box and Block Test.	Baseline to 4 weeks
Functional independence	Barthel Index (BI): Assessment of functional independence in activities of daily living using the Barthel Index. The Barthel Index is a standardized scale ranging from 0 to 100, where higher scores indicate greater functional independence.	Baseline to 4 weeks
Pain intensity and interference	Brief Pain Inventory (BPI): Assessment of pain severity and pain-related interference with daily activities using the Brief Pain Inventory. The BPI is a standardized scale with scores ranging from 0 to 10, where higher scores indicate greater pain intensity and greater interference with daily activities.	Baseline to 4 weeks
Stroke-related quality of life	Stroke Impact Scale (SIS): Evaluation of stroke-related quality of life across physical, emotional, and social domains using the Stroke Impact Scale. The SIS is a standardized patient-reported outcome measure with domain scores ranging from 0 to 100, where higher scores indicate better quality of life and functional status.	Baseline to 4 weeks
Muscle strength	Handgrip Strength Test (HST): Measurement of upper-limb muscle strength using handgrip dynamometry.	Baseline to 4 weeks
Patient satisfaction	Assessment of user satisfaction with assistive technology and system integration using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0). The QUEST 2.0 is a standardized questionnaire with item scores ranging from 1 to 5, where higher scores indicate greater user satisfaction. Clinically meaningful satisfaction is defined as a mean score ≥4.	4 weeks
Usability	System Usability Scale (SUS): Evaluation of system usability. A score ≥70 will be considered indicative of acceptable usability.	4 weeks
Safety and tolerability	Incidence of adverse events: Assessment of safety based on the number and severity of adverse events related to the intervention	Throughout study (up to 4 weeks)
Treatment adherence and discontinuation	Drop-out rate: Proportion of participants who discontinue the intervention before completion.	4 weeks

Collaborators and Investigators

• Sponsor: University of Campania Luigi Vanvitelli

Publications and helpful links

General Publications

• Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
• GBD 2019 Acute and Chronic Care Collaborators. Characterising acute and chronic care needs: insights from the Global Burden of Disease Study 2019. Nat Commun. 2025 May 7;16(1):4235. doi: 10.1038/s41467-025-56910-x.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: stroke; Telerehabilitation; Robotics; Hemiplegia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Paresis; Hemiplegia
• Other Study ID Numbers: Prot. 0010201/i del 10/04/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data underlying the results will be shared with researchers upon reasonable request, following publication of the study results. Data will be de-identified in accordance with applicable data protection regulations.
• IPD Sharing Time Frame: Starting 6 months after publication of the primary results; ending 5 years after publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No